FDA.reportPublic FDA data

simvastatin

Product NDC
53002-1527
11-digit product format
530021527
Labeler code
53002
Product ID
53002-1527_1cb72508-79af-40fb-b114-0929406ed44a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1527-02025-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-32025-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-92025-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-02023-06-07C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-32023-06-07C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-92023-06-07C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-02023-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-32023-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-92023-01-30C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-02020-12-15C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-32020-12-15C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-92020-12-15C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-02020-01-31C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-32020-01-31C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991
53002-1527-92020-01-31C16284748780-19d75b9d0-cc6d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1527-0simvastatin100 in 1 BOTTLETABLET, FILM COATED10013
53002-1527-3simvastatin30 in 1 BOTTLETABLET, FILM COATED3013
53002-1527-9simvastatin90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53002-1527-3EA - Each53002-152762ba4b53-234c-4cc1-a9f4-d60f7fb408cf12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1527SIMVASTATIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]13Legacy NDC, 3 package rows20230609_f2a20844-9918-40f6-be69-6dea54b877a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
312961simvastatin 20 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
198211simvastatin 40 MG Oral TabletPSNf2a20844-9918-40f6-be69-6dea54b877a713
314231simvastatin 10 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713
312961simvastatin 20 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713
198211simvastatin 40 MG Oral TabletSCDf2a20844-9918-40f6-be69-6dea54b877a713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1527-053002152700100 TABLET, FILM COATED in 1 BOTTLE (53002-1527-0) 2018-10-020000-00-00NoNoCurrent
53002-1527-35300215270330 TABLET, FILM COATED in 1 BOTTLE (53002-1527-3) 2018-10-020000-00-00NoNoCurrent
53002-1527-95300215270990 TABLET, FILM COATED in 1 BOTTLE (53002-1527-9) 2018-10-020000-00-00NoNoCurrent